Regulatory Site Officer

• Location: Swiftwater, PA

The RSO within the Regulatory Site Office supports regulatory compliance for marketed products by means of compliant and timely handling of regulatory activities at Swiftwater. The incumbent manages change control assessments and regulatory activities linked to change controls for the site, including the update of CMC files. These accountabilities include:

• Change Control Assessments
• PLC Management
• Authoring the variations, the CTD sections impacted by the changes, and the renewals of the site products registrations, in compliance with all applicable regulations and company processes
• Maintaining and updating regulatory files and databases
• Defining the potential regulatory impacts of changes made to the site products and services
• Ensuring compliance of the site products with all relevant product registrations, laws, regulations, standards, and guidelines in the markets where the site operates
• Assisting in internal and external audits, including regulatory inspections

• Bachelor's Degree
• 3 + years' experience in regulatory affairs, change control or technical writing
• OR 10 years in GxP regulated fields

Other Qualifications

• Experience with regulatory preparation of CMC dossier
• Well-developed communication skills, both verbal and written
• In-depth understanding of regulatory requirements and guidelines relevant to the pharmaceutical industry
• Ability to analyze complex regulatory documents and data to ensure compliance and identify potential issues
• Demonstrates initiative, analytical thinking and works independently
• Proficiency in managing multiple regulatory projects simultaneously, ensuring timely submissions and compliance
• High level of accuracy and attention to detail in preparing and reviewing regulatory documents and reports
• Experience working with a Health Authority is helpful but not essential

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
• Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.
• Power industry-leading performance by leveraging digital, data, and AI-driven innovation at speed and scale
• Transform lives worldwide by delivering life-changing treatments anywhere, anytime.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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